Progression of Metabolic Syndrome Components During Pregnancy

Launched by UNIVERSITY GHENT · Jun 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how certain health factors, known as metabolic syndrome (MetS), change during pregnancy and how they might affect birth outcomes in women from southwest Ethiopia. Specifically, the researchers want to understand what causes MetS during pregnancy, how it develops over time, and its relationship to problems that can occur during pregnancy and childbirth. They are looking for healthy pregnant women in their first trimester (less than 15 weeks) who are visiting the Jimma Medical Center for their first routine check-up.

To participate, women should be generally healthy but may have one of the risk factors associated with MetS, like high blood pressure or obesity. During the study, participants will be followed throughout their pregnancy and up to one month after giving birth, with assessments at several points to gather information about their health, diet, and pregnancy outcomes. This trial aims to provide important insights into how diet and lifestyle choices during pregnancy can affect both the mother and the baby.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Apparently healthy women with (or without) at least one of the 5 individual components of MetS will be enrolled in the study from each selected health institution if they meet all the inclusion criteria.
• Inclusion criteria for the exposed group include additionally:
• • 1. Abdominal obesity defined as waist circumference ≥ 2 standard deviations (SD) for gestational age in the first half of pregnancy or presentational BMI \>30 kg/m2, OR
• • 2. Raised triglycerides (\>1.70 mmol/l \[\>150 mg/dl\]), OR
• • 3. Reduced high-density lipoprotein cholesterol (\<1.29 mmol/l \[\<50 mg/dl\]), OR
• • 4. Raised blood pressure (BP) (i.e., systolic BP \>130 mm Hg or diastolic BP \>85 mm Hg), OR
• • 5. Raised plasma glucose (\>5.6 mmol/l).
• Exclusion Criteria:
• • Pregnant women with chronic hypertension that necessitates medication, diabetes (also under medication), or any severe chronic illness will not be eligible to participate in the study. Women who have HIV and who take antiretroviral therapy (ART) are also not eligible because of the side effect of ART. Additionally, non-consenting women, ≤18 years old, women who are planning to move outside the study area within the study timeframe due to job transfer or study leave, or those who are not willing to adhere to the prospective follow up visits will not be included in the study. Women whose ultrasound confirmed, twin pregnancy, congenital anomaly or fetal death in utero will not be included in the study.